Back to resultsImpact of Endovenous Water Vapor Treatment on Quality of Life in Superficial Venous Insufficiency of the Lower Limbs (INVOLVE)
Primary Purpose
Venous Insufficiency of Leg
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VBox Hybrid
Sponsored by
About this trial
This is an interventional treatment trial for Venous Insufficiency of Leg
Eligibility Criteria
Inclusion Criteria:
- Women who have been menopausal for at least 24 months, surgically sterilized, or, for women of childbearing potential, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches)
- Signature of the informed consent to participate indicating that the subject has understood the purpose and procedures required by the study and that he agrees to participate in the study and to comply with the requirements and restrictions inherent in this study
- Affiliation to a French social security scheme or beneficiary of such a scheme
- Patient with a reflux of the tributary veins, associated or not with a reflux of the large saphenous veins
- Patient with a reflux of the tributary veins already treated for a reflux at the saphenous level
- Clinical stage between C2 and C5 (from the CEAP classification). Diameter of the vein between 3 and 13 mm
- Patient treated with one or two lower limbs
- Patient able to understand and complete a quality of life questionnaire
Exclusion Criteria:
- Legal incapacity or limited legal capacity
- Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator
- Subject without health insurance
- Pregnant woman
- Subject in the period of exclusion from another study or provided for by the "national file of volunteers"
- Patient with an absolute or relative contraindication to the treatment of his varicose veins by an endovenous technique
- Venous insufficiency at the expense of the small saphenous vein
- Patient with a history of venous thrombosis
- Patient with hemostasis disorders
- Patient with an associated severe pathology (cancer, heart failure, renal failure)
- Patient treated with sclerotherapy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Experimental group
Arm Description
Treatment of the tributary veins by phlebectomy
Endovenous steam treatment of the tributary veins
Outcomes
Primary Outcome Measures
Comparison of the quality of life relative to the health of patients after endovenous steam treatment versus phlebectomy of the tributary veins
Questionnaire : VEnous INsufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) : target dimension " VEINES-QoL symptom summary score ". High values indicate better outcomes.
Secondary Outcome Measures
Comparison of the evolution of the quality of life relating to health of patients after endovenous steam treatment versus phlebectomy of the tributary veins
Questionnaires : VEnous INsufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym), 36-Item Short Form Survey Instrument (SF36).
The scores range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health.
Comparison of occlusion of the tributary veins after endovenous steam treatment versus phlebectomy of the tributary veins
Occlusion rate evaluated by Doppler ultrasound
Evaluation of the period of resumption of activity for people in activity after endovenous steam treatment versus phlebectomy of the tributary veins
Duration of work stoppage for working people
Full Information
NCT ID
NCT04534244
First Posted
August 4, 2020
Last Updated
August 31, 2020
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT04534244
Brief Title
Impact of Endovenous Water Vapor Treatment on Quality of Life in Superficial Venous Insufficiency of the Lower Limbs
Acronym
INVOLVE
Official Title
Management of Tributary Veins in Superficial Venous Insufficiency of the Lower Limbs: Impact of Endovenous Steam Treatment Versus Phlebectomy on Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The prevalence of superficial chronic venous insufficiency (CVI) of the lower limbs is estimated at 18 million French people. The number of patients operated for varicose veins is around 300,000 per year. Post-operative complications such as venous ulcer, venous thrombosis and varicose vein rupture require a lot of medical care. Varicose veins are responsible for a decrease in quality of life and represents 1 to 2% of total health expenditure.
Currently, operating techniques tend towards minimally invasive procedures in order to minimize the surgical trauma, improve patient comfort and reduce the time of postoperative work stoppages.
This study aims to compare two surgical techniques for the treatment of superficial chronic venous insufficiency of the lower limbs : phlebectomy, the gold-standard technique, and endovenous steam treatment. Several studies have already been carried out on endovenous steam treatment for saphenous veins but none has been published concerning the tributary veins.The main objective of INVOLVE is to assess the quality of life of patients 1 month after surgery. Clinical improvement and economic impact will also be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency of Leg
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Treatment of the tributary veins by phlebectomy
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Endovenous steam treatment of the tributary veins
Intervention Type
Device
Intervention Name(s)
VBox Hybrid
Intervention Description
Medical device intended to treat permanent venous insufficiency of saphenous veins and tributary veins in patients with superficial venous reflux
Primary Outcome Measure Information:
Title
Comparison of the quality of life relative to the health of patients after endovenous steam treatment versus phlebectomy of the tributary veins
Description
Questionnaire : VEnous INsufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) : target dimension " VEINES-QoL symptom summary score ". High values indicate better outcomes.
Time Frame
one month after the intervention
Secondary Outcome Measure Information:
Title
Comparison of the evolution of the quality of life relating to health of patients after endovenous steam treatment versus phlebectomy of the tributary veins
Description
Questionnaires : VEnous INsufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym), 36-Item Short Form Survey Instrument (SF36).
The scores range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health.
Time Frame
8-15 days, 3, 6, 9 and 12 months after the intervention
Title
Comparison of occlusion of the tributary veins after endovenous steam treatment versus phlebectomy of the tributary veins
Description
Occlusion rate evaluated by Doppler ultrasound
Time Frame
8-15 days and one year after the intervention
Title
Evaluation of the period of resumption of activity for people in activity after endovenous steam treatment versus phlebectomy of the tributary veins
Description
Duration of work stoppage for working people
Time Frame
up to 1 year
Other Pre-specified Outcome Measures:
Title
Comparison of secondary complications after endovenous steam treatment versus phlebectomy of the tributary veins
Description
The frequency, nature and severity of adverse events or immediate complications: hematomas, infections and burns requiring or not requiring intervention
Time Frame
8-15 days, 1, 6 and 12 months after the intervention
Title
Comparison of postoperative pain after endovenous steam treatment versus phlebectomy of the tributary veins
Description
Assessment of daily pain by the visual analogue pain assessment scale for 8 days. The scores range from zero where the respondent has the most pain to 10 where the respondent has the least pain.
Time Frame
Daily for the first 8 days after surgery
Title
Comparison of the clinical improvement felt by the patient
Description
Clinical improvement felt by the patient assessed by the Venous Clinical Severity Score (VCSS).
Scores that can be obtained range between 0 and 30. Low values indicate better outcomes.
Time Frame
1, 6 months and one year after the intervention
Title
Evaluation of the economic impact of endovenous steam treatment in the management of superficial venous insufficiency of the lower limbs (cost-utility and cost-effectiveness analyzes)
Description
Estimation of the differential cost-result ratio, evaluation of utility via EQ-5D Low values indicate better outcomes
Time Frame
8-15 days, 1, 3, 6, 9 and 12 months after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women who have been menopausal for at least 24 months, surgically sterilized, or, for women of childbearing potential, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches)
Signature of the informed consent to participate indicating that the subject has understood the purpose and procedures required by the study and that he agrees to participate in the study and to comply with the requirements and restrictions inherent in this study
Affiliation to a French social security scheme or beneficiary of such a scheme
Patient with a reflux of the tributary veins, associated or not with a reflux of the large saphenous veins
Patient with a reflux of the tributary veins already treated for a reflux at the saphenous level
Clinical stage between C2 and C5 (from the CEAP classification). Diameter of the vein between 3 and 13 mm
Patient treated with one or two lower limbs
Patient able to understand and complete a quality of life questionnaire
Exclusion Criteria:
Legal incapacity or limited legal capacity
Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator
Subject without health insurance
Pregnant woman
Subject in the period of exclusion from another study or provided for by the "national file of volunteers"
Patient with an absolute or relative contraindication to the treatment of his varicose veins by an endovenous technique
Venous insufficiency at the expense of the small saphenous vein
Patient with a history of venous thrombosis
Patient with hemostasis disorders
Patient with an associated severe pathology (cancer, heart failure, renal failure)
Patient treated with sclerotherapy
12. IPD Sharing Statement
Learn more about this trial
Impact of Endovenous Water Vapor Treatment on Quality of Life in Superficial Venous Insufficiency of the Lower Limbs
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